DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-18 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10-11, and 13-21 of U.S. Patent No. 12,318,414 in view of “Ryan et al.,” US 2018/0303552 (hereinafter Ryan).
Instant Application 19/205,208
Claims-05/12/2025
U.S. Patent No. 12,318,144
1. A method, comprising, by at least one processor:
measuring spinal parameters of a spine in a pre-operative spinal image, the spinal parameters including at least a pre-operative Cobb angle and a pre-operative kyphosis;
identifying a kyphosis goal having a post-operative kyphosis value for a selected set of spine elements;
creating a post-operative spinal image representation using a predictive model including machine-learning algorithms trained on medical images of other patients having a kyphosis;
determining a first rod design based on the post operative spinal image representation to achieve the post-operative kyphosis value in the selected set of spine elements;
determining a deformation signature response of a first rod contoured to a geometry of the first rod design based on a material the first rod is made of;
determining a second rod design based on the first rod design, the second rod design configured to compensate for the deformation signature response of the first rod;
and generating instructions to manufacture a rod according to a geometry of the second
rod design.
2. The method of claim 1, further comprising, by the at least one processor:
displaying a graphical user interface including an image representative of the rod relative to the spine.
3. The method of claim 1, further comprising, by the at least one processor: determining a surgical strategy; and
while determining the surgical strategy, performing at least one of: determining rod cutting parameters to cut the rod according to the geometry of the second rod design, determining in situ rod bending techniques to cut the rod according to the geometry of the second rod design, or bending the rod to conform to the geometry of the second rod design.
4.The method of claim 1, wherein identifying the kyphosis goal having the post-operative kyphosis value to the selected set of spine elements comprises selecting the set of spine elements to treat an adolescent idiopathic scoliosis deformity.
5.The method of claim 1, further comprising, by the at least one processor: segmenting the pre-operative spinal image; and identifying levels of vertebrae in the segmented pre-operative spinal image, wherein measuring the spinal parameters of the spine comprises measuring the spinal parameters of the spine based on the identified levels of the vertebrae.
6. The method of claim 1, wherein determining the deformation signature response of the rod comprises determining the deformation signature response based on rod diameter and/or rod length.
7. The method of claim 1, wherein determining the deformation signature response of the rod comprises using a machine-learning algorithm trained on pre-operative and post-operative contours of rods made of the material.
8. The method of claim 7, wherein using the machine-learning algorithm trained on pre-operative and post-operative contours comprises using a machine-learning
algorithm trained on image data of pre-operative and post-operative rod contours.
9. The method of claim 1, wherein determining the second rod design comprises configuring the second rod design to compensate for the deformation signature
response of the rod due to in vivo deforming forces.
10. The method of claim 9, wherein configuring the second rod design to compensate for the deformation signature response comprises configuring the second rod
design to compensate for overbending due to in vivo deforming forces.
11.A system, comprising:
at least one processor; and
a non-transitory and tangible computer readable storage medium having programming instructions stored thereon, which when executed are configured to cause
the at least one processor to:
measure spinal parameters of a spine in a pre-operative spinal image, the spinal parameters including at least a pre-operative Cobb angle and a pre-operative
kyphosis;
identify a kyphosis goal having a post-operative kyphosis value for a selected set of spine elements;
create a post-operative spinal image representation using a predictive model including machine-learning algorithms trained on medical images of other patients
having a kyphosis;
determine a first rod design based on the post-operative spinal image representation to achieve the post-operative kyphosis value in the selected set of spine elements;
determine a deformation signature response of a first rod contoured to a geometry of the first rod design based on a material the first rod is made of;
determine a second rod design based on the first rod design, the second rod design configured to compensate for the deformation signature response of the first
rod; and
generate instructions to manufacture a rod according to a geometry of the second rod design.
12. The system of claim 11, further comprising programming instructions, which when executed are configured to cause the at least one processor to:
display a graphical user interface comprising:
an image representative of the rod relative to the spine.
13. The system of claim 11, further comprising programming instructions, which when executed are configured to cause the at least one processor to:
determine a surgical strategy; and
while determining the surgical strategy, perform at least one of:
determine rod cutting parameters to cut the rod according to the geometry of the second rod design,
determine in situ rod bending techniques to cut the rod according to the geometry of the second rod design, or
bending the rod to conform to the geometry of the second rod design.
14. The system of claim 11, further comprising programming instructions,
which when executed are configured to cause the at least one processor to:
segment the pre-operative spinal image; and
identify levels of vertebrae in the segmented pre-operative spinal image,
wherein the programming instructions that are configured to cause the at least one processor to measure the spinal parameters of the spine comprise programming instructions that are configured to cause the at least one processor to measure the spinal
parameters of the spine based on the identified levels of the vertebrae.
15. The system of claim 11, wherein the programming instructions that are configured to cause the at least one processor to determine the deformation signature
response of the rod comprise programming instructions that are configured to cause the at least one processor to determine the deformation signature response based on rod diameter and/or rod length.
16. The system of claim 15, wherein the programming instructions that are configured to cause the at least one processor to determine the deformation signature
response comprise programming instructions that are configured to cause the at least one processor to use a machine-learning algorithm trained on pre-operative and post-operative contours of rods made of the material.
17. The system of claim 16, wherein the programming instructions that are configured to cause the at least one processor to use the machine-learning algorithm
trained on pre-operative and post-operative contours comprise programming instructions that are configured to cause the at least one processor to use a machine-learning algorithm trained on image data of pre-operative and post-operative rod contours.
18. The system of claim 11, wherein the programming instructions that are configured to cause the at least one processor to determine the second rod design comprise
programming instructions that are configured to cause the at least one processor to configure the second rod design to compensate for the deformation signature response of the rod due to in vivo deforming forces.
20. A method, comprising:
planning a surgery to correct a spinal deformity according to the method of claim 1;
obtaining a rod formed of biocompatible material configured to approximate the second rod design;
during surgery, bending the rod to create a bent rod conforming to the second rod design; and
implanting the bent rod.
1. A method, comprising: by at least one processor: measuring spinal parameters of a spine in a two-dimensional (2D) pre-operative spinal image including at least a pre-operative thoracic Cobb angle and a pre-operative thoracic kyphosis; transforming the 2D pre-operative spinal image to a three-dimensional (3D), pre-operative spinal image representation by: performing segmentation of spine elements in the 2D pre-operative spinal image, and applying a mathematical formula based on the pre-operative thoracic Cobb angle and the pre-operative thoracic kyphosis to the spine elements; identifying a thoracic kyphosis goal having a post-operative thoracic kyphosis value to a selected set of the spine elements; transforming a gap of the spine elements representative of a difference between the pre-operative thoracic kyphosis in the 3D pre-operative spinal image representation and the thoracic kyphosis goal to create a 3D post-operative spinal image representation using a predictive model of gap transformation, the predictive model including machine-learning algorithms trained on medical images of other patients having a thoracic kyphosis; and determining a first rod design based on the 3D post-operative spinal image representation to achieve the post-operative thoracic kyphosis value in the selected set of spine elements; determining a deformation signature response of a rod contoured to a geometry of the first rod design based on a material the rod is made of; and determining a second rod design based on the first rod design, the second rod design configured to compensate for the deformation signature response of the rod.
2. The method of claim 1, further comprising, by the at least one processor: displaying a graphical user interface including an image representative of the first rod geometry and the second rod geometry relative to the spine.
3. The method of claim 1, further comprising, by the at least one processor: determining a surgical strategy; and while determining the surgical strategy, performing at least one of: determining rod cutting parameters to cut the second rod geometry, determining in situ rod bending techniques to cut the second rod geometry, or bending a rod to conform to the second rod geometry.
4. The method of claim 1, wherein identifying the thoracic kyphosis goal having the post-operative thoracic kyphosis value to the selected set of the spine elements comprises selecting the set of spine elements to treat an adolescent idiopathic scoliosis deformity.
5. The method of claim 1, further comprising, by the at least one processor: segmenting the 2D pre-operative spinal image; and identifying levels of vertebrae in the segmented 2D pre-operative spinal image, wherein the measuring of the spinal parameters of the spine is based on the identified levels of the vertebrae.
6. A system, comprising: at least one processor; and a non-transitory and tangible computer readable storage medium having programming instructions stored thereon, which when executed are configured to cause the at least one processor to: measure spinal parameters of a spine in a two-dimensional (2D) pre-operative spinal image including at least a pre-operative thoracic Cobb angle and a pre-operative thoracic kyphosis; transform the 2D pre-operative spinal image to a three-dimensional (3D), pre-operative spinal image representation by: performing segmentation of spine elements in the 2D pre-operative spinal image, and applying a mathematical formula based on the pre-operative thoracic Cobb angle and the pre-operative thoracic kyphosis to the spine elements; identify a thoracic kyphosis goal having a post-operative thoracic kyphosis value to a selected set of the spine elements; transform a gap of the spine elements representative of a difference between the pre-operative thoracic kyphosis in the 3D pre-operative spinal image representation and the thoracic kyphosis goal to create a 3D post-operative spinal image representation using a predictive model of gap transformation, the predictive model including machine-learning algorithms trained on medical images of other patients having a thoracic kyphosis; determine a first rod design based on the 3D post-operative spinal image representation to achieve the post-operative thoracic kyphosis value in the selected set of spine elements; determine a deformation signature response of a rod contoured to a geometry of the first rod design based on a material the rod is made of; and determine a second rod design based on the first rod design, the second rod design configured to compensate for the deformation signature response of the rod.
7. The system of claim 6, further comprising programming instructions, which when executed are configured to cause the at least one processor to: display a graphical user interface comprising: an image representative of the first rod geometry and the second rod geometry relative to the spine.
8. The system of claim 6, further comprising programming instructions, which when executed are configured to cause the at least one processor to: determine a surgical strategy; and while determining the surgical strategy, perform at least one of: determine rod cutting parameters to cut the second rod geometry, determine in situ rod bending techniques to cut the second rod geometry, or bending a rod to conform to the second rod geometry.
10. The system of claim 6, further comprising programming instructions, which when executed are configured to cause the at least one processor to: segment the 2D pre-operative spinal image; and identify levels of vertebrae in the segmented 2D pre-operative spinal image, wherein the measuring of the spinal parameters of the spine is based on the identified levels of the vertebrae.
11. A method, comprising: planning a surgery to correct a spinal deformity according to the method of claim 1; obtaining a rod formed of biocompatible material configured to approximate the second a first-rod design; during the surgery, bending the rod to create a bent rod conforming to the second first-rod design; and implanting the bent rod.
13. The method of claim 1, wherein determining the deformation signature response of the rod comprises determining the deformation signature response based on rod diameter and/or rod length.
14. The method of claim 1, wherein determining the deformation signature response of the rod comprises using a machine-learning algorithm trained on pre-operative and post-operative contours of rods made of the material.
15. The method of claim 14, wherein using the machine-learning algorithm trained on pre-operative and post-operative contours comprises using a machine-learning algorithm trained on 2D image data of pre-operative and post-operative rod contours.
16. The method of claim 1, wherein determining the second rod design comprises configuring the second rod design to compensate for the deformation signature response of the rod due to in vivo deforming forces.
17. The method of claim 16, wherein determining the second rod design comprises configuring the second rod design to compensate for overbending due to in vivo deforming forces.
18. The system of claim 6, wherein the programming instructions that are configured to cause the at least one processor to determine the deformation signature response of the rod comprise programming instructions that are configured to cause the at least one processor to determine the deformation signature response based on rod diameter and/or rod length.
19. The system of claim 6, wherein the programming instructions that are configured to cause the at least one processor to determine the deformation signature response of the rod comprise programming instructions that are configured to cause the at least one processor to use a machine-learning algorithm trained on pre-operative and post-operative contours of rods made of the material.
20. The system of claim 19, wherein the programming instructions that are configured to cause the at least one processor to use the machine-learning algorithm trained on pre-operative and post-operative contours comprises programming instructions that are configured to cause the at least one processor to use a machine-learning algorithm trained on 2D image data of pre-operative and post-operative rod contours.
21. The system of claim 6, wherein the programming instructions that are configured to cause the at least one processor to determine the second rod design comprises programming instructions that are configured to cause the at least one processor to configure the second rod design to compensate for the deformation signature response of the rod due to in vivo deforming forces.
Regarding to claims 1 and 11, patented claims 1 and 6 set forth the limitations except the underlined limitations.
Patented claim further discloses bolded limitations, however, the claim under examination is not patentably distinct from the patented claim, since claim under examination recites “image: and “kyphosis” is generic to “3E, 2D,” and “thoracic kyphosis” and “transforming” species claimed in patented claims 1 and 6. Species in the patented claim anticipates the claimed genus in the application being examined and therefore, a patent to the genus would improperly extend the right to exclude granted by a patent to the species or sub0genus should the genus issue as a patent after the species or sub-genus.
Patented claim does not set forth the further limitations of claims 1 and 11 under examination of “generating instructions to manufacture a rod according to a geometry of the second rod design.”
In the analogous kyphosis analysis of brain field of endeavor, Ryan makes obvious the limitations set forth above, since Ryan explicitly teaches generating spinal rod manufacturing or selection data instructions based on determined parameters ([0016]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method and apparatus as taught by patented claim(s) 1 and 6 to be as claimed in the instant application, since such limitations were well known in the art as made obvious by Ryan. One of ordinary skill in the art could have combined the elements as claimed by known methods (e.g. programming or generating instructions to manufacture rod) with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide generate instructions to manufacture rods specifically customized for a particular patient ([0053]), and there was reasonable expectation of success.
Regarding to claim 2, patented claim 2 set forth the underlined limitations.
Regarding to claim 3, patented claim 3 set forth the underlined limitations.
Regarding to claim 4, patented claim 4 set forth the underlined limitations.
Regarding to claim 5, patented claim 5 set forth the underlined limitations.
Regarding to claim 6, patented claim 13 set forth the underlined limitations.
Regarding to claim 7, patented claim 14 set forth the underlined limitations.
Regarding to claim 8, patented claim 15 set forth the underlined limitations.
Regarding to claim 9, patented claim 16 set forth the underlined limitations.
Regarding to claim 10, patented claim 17 set forth the underlined limitations.
Regarding to claim 12, patented claim 7 set forth the underlined limitations.
Regarding to claim 13, patented claim 8 set forth the underlined limitations.
Regarding to claim 14, patented claim 10 set forth the underlined limitations.
Regarding to claim 15, patented claim 18 set forth the underlined limitations.
Regarding to claim 16, patented claim 19 set forth the underlined limitations.
Regarding to claim 17, patented claim 20 set forth the underlined limitations.
Regarding to claim 18, patented claim 21 set forth the underlined limitations.
Regarding to claim 20, patented claim 11 set forth the underlined limitations.
Reasons for Indicating Allowable Subject Matter
Claims 1 and 11 are allowable.
The following is an examiner’s statement of reasons for indicating allowable subject matter allowance:
The following prior art previously made of record is considered pertinent to the reasons of allowance:
Ryan (US2018/0303552) teaches planning thoracic kyphosis correction with cobb angles ([0239]) and generating a prediction of post operative variables based on predictive model ([0007], [0075]), and simulating a spine rod ([0005]).
Schroeder (US2021/024447) teaches planning orthopedic surgical procedures including thoracic kyphosis and correction method includes using rods of different bends, material, geometry and order of application and making changes in spinal deformity ([0036]).
However, the prior art previously and currently made of record fails to disclose or make obvious the limitation “determining a second rod design based on the first rod design, compensate for the deformation signature response of the rod based on a material the rod is made of the first rod design” in combination with the rest of the limitations of independent claim(s) 1 and 11. There is no reason absent hindsight to have combined and modified teachings of the cited references before the effective filing date of the claimed invention for a user to incorporate teaching of the limitations in combination with prior arts, in order to produce the claimed invention. Furthermore, such a configuration allows provide a patient specific rod designs ([0061]) advantages claimed by present invention.
Therefore, claims 1 and 11 overcome previously and currently cited prior art and is/are found to be allowable when amended or filing terminal disclaimer to overcome double patenting rejection set forth above.
Conclusion
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/PATRICIA J PARK/Primary Examiner, Art Unit 3798
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